COMBINE Pilot Phase 2 – coordinated assessment of combined clinical trial and medical device or in vitro diagnostic studies

Clinical trial sponsors can now take part in Phase 2 of the COMBINE Pilot. The COMBINE pilot is part of a European Commission programme to test the feasibility of a coordinated assessment for combined studies.

Combined studies involve a clinical trial of a medicinal product in parallel with either 

• A performance study of an in-vitro diagnostic or
• A clinical investigation of a medical device

COMBINE Phase 2 is now open for submissions and is expected to remain open until late 2027. Sponsors planning combined studies are encouraged to submit applications.

Key changes in Phase 2 

Phase 2 of the pilot aims to build on the success of Phase I and expand the scope of accepted applications to include medical device studies and studies involving Advanced Therapy Medicinal Products (ATMPs).

It also allows for the clinical trial and performance study or clinical investigation to have different sponsors. 

Why take part? 

Participation offers sponsors an opportunity to have combined studies assessed through a coordinated approach with the aim of reducing the administrative burden, streamlining the authorisation process and accelerating patient access to innovative treatments.

Those who take part can provide feedback on how this approach works in practice which will help inform the development of combined coordinated assessment in Europe.  

For further details, including how to take part, visit our EU Clinical Trial Initiatives webpage.